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BioWorld - Sunday, December 21, 2025
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U.S. Capitol building

Tax Foundation report says resumption of device tax would hit GDP by $1.7B

Dec. 3, 2019
By Mark McCarty
The impending resumption of the 2.3% tax on medical devices has industry actively seeking at least a new suspension. Now, the Tax Foundation, of Washington, has issued a report saying that the tax would cost more than 21,000 Americans their jobs and impose a $1.7 billion hit on the U.S. economy.
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Righeye-system-12-3.png

Righteye wins breakthrough device designation for Parkinson’s test

Dec. 3, 2019
By Meg Bryant

The U.S. FDA has granted breakthrough device designation for Righteye LLC’s eye movement-tracking vision system as a test for Parkinson’s disease. Developed by researchers at PADRECC and Virginia Commonwealth University with funding from the Michael J. Fox Foundation, and licensed to Righteye in 2016, the test requires patients to sit in front of an all-in-one tablet-looking device and follow a series of moving targets. The goal is to identify ocular tremors, a persistent issue with Parkinson’s patients that prevents steady fixation on objects and images. The noninvasive test, which measures an individual’s ability to follow objects on a screen, could help doctors not only confirm the difficult-to-diagnose disease, but also detect it at earlier stages.


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Stephen Hahn, nominee for FDA commissioner

Hahn just a Senate vote away from becoming the FDA’s next commissioner

Dec. 3, 2019
By Mari Serebrov
With today’s 18-5 vote in the Senate Health, Education, Labor and Pensions (HELP) Committee to send Stephen Hahn’s nomination to the full U.S. Senate, the oncologist who currently serves as chief medical officer at the MD Anderson Cancer Center is just a step away from being confirmed as the next FDA commissioner.
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Ear illustration

FDA gives thumbs up to Cochlear’s implantable bone conduction hearing system

Dec. 3, 2019
By Tamra Sami
The U.S. FDA has cleared Cochlear Ltd.’s newest cochlear implant, the Osia 2 system, an active implantable bone conduction hearing system. Unlike Cochlear’s traditional implant, the Osia implant bypasses damaged parts of the ear and sends sound vibrations directly to the cochlea.
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Regulatory front for Dec. 3, 2019

Dec. 3, 2019
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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Regulatory front for Dec. 3, 2019

Dec. 3, 2019
The latest global regulatory news, changes and updates affecting biopharma.
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U.S. flag, stethoscope

Stakeholders press CMS to allow repeat testing in do-over of NGS coverage memo

Dec. 2, 2019
By Mark McCarty
The Medicare coverage memo for next-generation DNA sequencing (NGS) was reopened to allow for NGS testing for other than late-stage cancers, but stakeholders are urging the U.S. Centers for Medicare and Medicaid Services (CMS) to allow repeat testing, another change that would considerably boost utilization.
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China updates reimbursement drug list, further encourages innovation at home

Dec. 2, 2019
By Elise Mak
BEIJING – China has updated its national reimbursement drug list (NRDL) to include innovative drugs that it has recently approved, including homegrown cancer drugs and foreign imports. Industry experts said they believe it is a move to drive biotech innovation at home.
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Regulatory front for Dec. 2, 2019

Dec. 2, 2019
The latest global regulatory news, changes and updates affecting biopharma.
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Regulatory front for Dec. 2, 2019

Dec. 2, 2019
The latest global regulatory news, changes and updates affecting medical devices and technologies.
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